CALCIUM ACETATE

25/100 · Low Risk

Manufactured by Amneal Pharmaceuticals of New York LLC

Low Serious Event Ratio for Calcium Acetate

Last updated: 2026-05-12

About CALCIUM ACETATE

CALCIUM ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals of New York LLC. Based on analysis of FDA adverse event reports, CALCIUM ACETATE has a safety score of 25 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CALCIUM ACETATE.

AI Safety Analysis

Calcium Acetate has a safety concern score of 25 out of 100, placing it in the low concern category based on analysis of FDA adverse event data. The FDA has received approximately N/A adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Of New York Llc.

Of classified reports, 74.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. No serious events reported in the latest data.

The majority of reported events are non-serious. The serious event ratio is low at 74.5%.

Patients taking Calcium Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 25/100

Calcium Acetate received a safety concern score of 25/100 (low concern). This is based on a 74.5% serious event ratio across 5,219 classified reports. The score accounts for N/A total adverse event reports and 0 distinct reaction types. This relatively low score suggests a favorable safety profile in reported data.

Key Safety Signals

  • Low serious event ratio
  • High non-serious event ratio

Patient Demographics

Demographic data for adverse event reporters is limited for this medication.

Report Outcomes

Out of 5,219 classified reports for CALCIUM ACETATE:

  • Serious: 3,887 reports (74.5%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 1,332 reports (25.5%)
Serious 74.5%Non-Serious 25.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

What You Should Know

If you are taking Calcium Acetate, here are important things to know. Monitor for any unusual symptoms and report them to your healthcare provider. Follow prescribed dosage instructions carefully. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Frequently Asked Questions

How many adverse event reports has the FDA received for Calcium Acetate?

The FDA has received approximately N/A adverse event reports associated with Calcium Acetate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

What percentage of Calcium Acetate adverse event reports are serious?

Out of 5,219 classified reports, 3,887 (74.5%) were classified as serious and 1,332 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

Who manufactures Calcium Acetate?

The primary manufacturer associated with Calcium Acetate adverse event reports is Amneal Pharmaceuticals Of New York Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

How do I report a side effect from Calcium Acetate?

You can report adverse events from Calcium Acetate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Calcium Acetate's safety score and what does it mean?

Calcium Acetate has a safety concern score of 25 out of 100 (low concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. No serious events reported in the latest data.

What are the key safety signals for Calcium Acetate?

Key safety signals identified in Calcium Acetate's adverse event data include: Low serious event ratio. High non-serious event ratio. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

What should patients know before taking Calcium Acetate?

Monitor for any unusual symptoms and report them to your healthcare provider. Follow prescribed dosage instructions carefully.

Are Calcium Acetate side effects well-documented?

Calcium Acetate has N/A adverse event reports on file with the FDA. The majority of reported events are non-serious. The volume of reports for Calcium Acetate reflects both the drug's usage level and the vigilance of the reporting community.

Related Drugs

Drugs related to CALCIUM ACETATE based on therapeutic use, drug class, or shared indications:

Amneal Pharmaceuticals of New York LLC
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.